Acceptance and Value Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes
Acceptance and Value Based Based Methods in Increasing Wellbeing of Adolescents With Type 1 Diabetes / Hyväksyntä- ja Arvopohjaiset menetelmät Diabetesta Sairastavien Nuorten Hyvinvoinnin edistämisessä
1 other identifier
interventional
60
1 country
1
Brief Summary
The aim of the study is to study how using acceptance and value based group intervention helps the wellbeing of teenagers with type in diabetes. The investigators created an ACT-group intervention consisting of five sessions, based on earlier research. 12-16 years- old diabetics who are treated at KSSHP pediatric policlinic are invited to join the groups. The participants are randomized to research and control groups. The HbA1c-level is monitored for both groups as well as the psychological flexibility, diabetes related acceptance, depression and quality of life.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable diabetes
Started Oct 2015
Longer than P75 for not_applicable diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
January 30, 2017
CompletedFirst Posted
Study publicly available on registry
January 31, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2021
CompletedAugust 13, 2021
May 1, 2019
4.6 years
January 30, 2017
August 12, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Glycemic control
HbA1c
up to 8 months
Secondary Outcomes (4)
Quality of life assessed by KINDL-r Questionnaire
up to 8 months
Diabetes Related Psychological flexibility assessed by DAAS
up to 8 months
Depressive symptoms assessed by RBDI
up to 8 months
Psychological flexibility assessed by CAMM
up to 8 months
Study Arms (2)
research group
EXPERIMENTALResearch group is attending the ACT intervention first and from before and afte measurement are compared to the control group
control group
ACTIVE COMPARATORControl group is offered to attend the intervention afterwards
Interventions
Eligibility Criteria
You may qualify if:
- type 1 diabetes
You may not qualify if:
- weekly psychiatric appointments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Central Finland Hospital Districtlead
- University of Jyvaskylacollaborator
- Finnish Diabetes Associationcollaborator
Study Sites (1)
Iina Alho
Jyväskylä, 40620, Finland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Raimo Lappalainen, PhD
supervisor
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2017
First Posted
January 31, 2019
Study Start
October 1, 2015
Primary Completion
May 1, 2020
Study Completion
May 1, 2021
Last Updated
August 13, 2021
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share